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The Efficacy of Tianeptine Versus Pregabalin on Acute and Chronic Post Mastectomy Pain After Breast Cancer Surgery.

NCT05935059 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-03-10

No results posted yet for this study

Summary

Breast cancer is the most common malignancy among females. Nearly 40% of breast surgery patients experience moderate to severe acute postoperative pain, with severe pain persisting for more than 6 months in almost 20-50% of patients (post mastectomy pain syndrome) which is defined according to International Association for the Study of Pain (IASP) as pain which persists more than 3 months after mastectomy/lumpectomy affecting the anterior thorax, axilla, and/or medial upper arm. Different pharmacological tools have been in use for either prevention or treatment of such refractory pain syndrome with variable efficacy. The aim of this study is to assess the efficacy of the perioperative use of Pregabalin versus Tianeptine on the emergence of PMPS in female patients undergoing MRM for breast cancer.

Conditions

  • Post-mastectomy Pain Syndrome

Interventions

DRUG

Pregabalin

Pregabalin 50Mg Oral Capsule. Pre-operative administration of Pregabalin for prevention of Post mastectomy Pain Syndrome (PMPS)

DRUG

Tianeptine

Tianeptine 12.5Mg Capsules. Prevention of Post Mastectomy Pain Syndrome

Sponsors & Collaborators

  • National Cancer Institute, Egypt

    lead OTHER

Principal Investigators

  • Ayman Sharawy Abdel Rahman Aboul Nasr, MD · National Cancer Institute Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-21
Primary Completion
2025-03-01
Completion
2025-03-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05935059 on ClinicalTrials.gov